Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030863060

FEI Number

3030863060

Entity Name

OSSEO PURE INC

City/State/Country

Lancaster, NY, US

Establishment Address

4401 Walden Ave, Ste 1, Lancaster, NY 14086, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSSEO PURE INC (Owner Number: 10090300)

Owner / Operator Contact Address

4401 Walden Ave, Ste 1, Lancaster, NY 14086, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OSSEO PURE Retaining Screw For Pilaster TiBase OSSEO PURE Retaining Screw For MUA Conic Old Style OSSEO PURE Spherical Prosthetic Screw MUA, Long OSSEO PURE Cognac Prosthetic Screw Structured Pilaster OSSEO PURE Retaining Screw For Flat One Long OSSEO PURE Spherical Prosthetic Screw MUA, Short OSSEO PURE Prosthetic Screw For Pilaster Short OSSEO PURE Retaining Screw Driver, Swivel Short OSSEO PURE Prosthetic Screw For Pilaster Long OSSEO PURE Cognac Prosthetic Screw M1.6x0.35 OSSEO PURE Cognac Prosthetic Screw MUA OSSEO PURE Retaining Screw Driver, Swivel Long

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2024-03-10

Official Correspondent

Waldemar Blaszak

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OSSEO PURE INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3017896270	EXCELLENT PRECISION TECHNOLOGY (DONGGUAN) CO., LTD	Dongguan Guangdong, CN
3042200066	HUB BIOTECH CO., LTD.	BUCHEON-SI Gyeonggi, KR
3042852773	COVISION CO., LTD.	Incheon, KR
3009847764	GMI DENTAL IMPLANTOLOGY, S.L.	Lleida Lerida, ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030863060. Last updated year: 2026. Please use registration number 3030863060 when referencing this establishment in official correspondence.